Ms&T Director – Sterile Technical Sme (Visual Inspection)

Buscojobs; Lombardia; Remoto; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking an MS&T Director – Sterile Technical SME specializing in Visual Inspection. This role involves improving global visual inspection processes, supporting troubleshooting efforts, and offering expertise in pharmaceutical manufacturing. Ideal candidates should have an MSc in a related field and significant GMP experience. The position offers full-time employment with 30-40% travel required.

Competenze

• Significant career experience in GMP manufacturing relevant to the specialist area of expertise.
• Validated process understanding regarding Pharma, GMP, and regulatory aspects.
• Up to 30-40% travel as needed.

Mansioni

• Offer expertise in visual inspection for pharmaceutical processes.
• Assistant in strategy creation and setting global standards.
• Support troubleshooting and harmonize technical processes.

Conoscenze

Expertise in visual inspection processes

Knowledge of common VI technologies

Confident communicator

Ability to influence others

Leadership skills

Formazione

MSc in Pharmacy or related field

Descrizione del lavoro

MS&T Director – Sterile Technical SME (Visual Inspection)

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MS&T Director – Sterile Technical SME (Visual Inspection)

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Work Schedule

Standard Office Hours (40 / wk)

Environmental Conditions

Office

Position : MS&T Director – Sterile Technical SME (Visual Inspection)

Reports To : DPD Division MSAT Head

Location : Remote (EU / US)

Preferred Locations :

• Italy : Monza & Ferentino
• UK : Swindon
• North Carolina (US) : Greenville
• France : Bourgoin

These locations are key sites for our operations

Position Summary

Work for Thermo Fisher Scientific as a Global Technical SME in Visual Inspection. Contribute to improve visual inspection process globally.

Key responsibilities

Manufacturing Support :

Offer expertise in visual inspection for pharmaceutical processes, assist in strategy creation, set global standards, and ensure consistency in DPD sterile sites

Offer significant expertise on common VI technologies / equipment (Manual / Semi-automatic / Automatic) and Leak Detection systems

Knowledgeable about AI application to AVI (e.g., recipes creation / optimization, support to validation)

Perform process characterization of related pharmaceutical processes to increase robustness and sustainability

Support sites in troubleshooting / root cause investigation by providing second-level specialist expertise and harmonizing related technical processes across units

Review sterile site aseptic practices and set a plan for improvements and adaptations

Work closely with sterile manufacturing site teams to efficiently implement new technologies and ensure timely product launches

Monitor GMP, EU, and FDA regulatory changes and requirements, review industry-specific journals and periodicals

Support projects requiring expertise in aseptic manufacturing and lyophilization technology

Provide technical support in aseptic manufacturing, validation, new technologies, and sterilization; facilitate IQ, OQ, and PQ equipment and process qualifications upon request

Identify and drive opportunities for improvement, suggesting ways to improve process effectiveness, product quality, and operating efficiency

Support the development of Training Curriculum for Site SMEs and assure alignment across sites

Provide training and education on related technologies to site employees

Stewardship for Aseptic Network & New Product Launch :

Serve as the Network SME, collaborating with local and global MSAT networks to establish technical standards for current and upcoming technologies and equipment.

Assure internal and external benchmarking to stimulate knowledge, growing associates' know-how and spreading it across the organization

Author and implement GOPs for assigned technologies

Qualifications And Requirements

MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field

Significant career experience in GMP manufacturing relevant to the specialist area of expertise

Validated process understanding (Pharma, GMP, Regulatory aspects)

Up to 30-40% travel, as needed

Confident communicator both verbally and in writing

Able to influence others and build cross-functional teams while setting clear business objectives

Proven leadership and technical experience

Seniority level

Seniority level

Not Applicable

Employment type

Employment type

Full-time

Job function

Job function

Production, Supply Chain, and Manufacturing

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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